An accurate and inexpensive color-based assay for detecting severe anemia in a limited-resource setting

• Type of Material: Article
• Authors: Patrick T. McGann, Cincinnati Children’s Hospital Medical Center; Erika A. Tyburski, Emory University; Vysolela de Oliveira, Hospital Pediátrico David Bernardino; Brigida Santos, Hospital Pediátrico David Bernardino; Russell E. Ware, Cincinnati Children’s Hospital Medical Center; Wilbur Lam, Emory University
• Language: English
• Date: 2015-12-01
• Publisher: Wiley
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2015 Wiley Periodicals, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1002/ajh.24180
• Title of Journal or Parent Work: American Journal of Hematology
• ISSN: 0361-8609
• Volume: 90
• Issue: 12
• Start Page: 1122
• End Page: 1127
• Grant/Funding Information: Cincinnati Children’s Research Foundation, FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children’s Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing, and the InVenture Prize and Ideas to Serve competitions at the Georgia Institute of Technology.
• Keywords: VALIDATION; Science & Technology; HEMOGLOBIN; SYSTEM; Life Sciences & Biomedicine; CAPILLARY; BLOOD; Hematology; SCALE; HEMOCUE; TETRAMETHYLBENZIDINE
• Research Categories: Health Sciences, Public Health; Health Sciences, Pathology

Abstract

Severe anemia is an important cause of morbidity and mortality among children in resource-poor settings, but laboratory diagnostics are often limited in these locations. To address this need, we developed a simple, inexpensive, and color-based point-of-care (POC) assay to detect severe anemia. The purpose of this study was to evaluate the accuracy of this novel POC assay to detect moderate and severe anemia in a limited-resource setting. The study was a cross-sectional study conducted on children with sickle cell anemia in Luanda, Angola. The hemoglobin concentrations obtained by the POC assay were compared to reference values measured by a calibrated automated hematology analyzer. A total of 86 samples were analyzed (mean hemoglobin concentration 6.6 g/dL). There was a strong correlation between the hemoglobin concentrations obtained by the POC assay and reference values obtained from an automated hematology analyzer (r=0.88, P<0.0001). The POC assay demonstrated excellent reproducibility (r=0.93, P<0.0001) and the reagents appeared to be durable in a tropical setting (r=0.93, P<0.0001). For the detection of severe anemia that may require blood transfusion (hemoglobin <5 g/dL), the POC assay had sensitivity of 88.9% and specificity of 98.7%. These data demonstrate that an inexpensive (<$0.25 USD) POC assay accurately estimates low hemoglobin concentrations and has the potential to become a transformational diagnostic tool for severe anemia in limited-resource settings.